Prescription drug · ANDA
Mesalamine Rectal (Mesalamine) NDC 69918-560
Mesalamine 1000 mg/1 · Suppository · Rectal · Amring Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69918-560-30 | 6991805603069918056030 | 30 SUPPOSITORY in 1 BOX (69918-560-30)Marketed from Jun 24, 2019 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Mesalamine Rectal
- Generic name (nonproprietary)
- mesalamine
- Active ingredients
- Mesalamine — 1000 mg/1
- Dosage form
- Suppository
- Route
- Rectal
- Labeler
- Amring Pharmaceuticals Inc.NDC labeler code 69918
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208362
- Marketing start
- Listing expires
- Other FDA classes
- Aminosalicylic Acids (Chemical structure)
- Identifiers
- Product ID 69918-560_795356f9-9817-4b51-8de6-4504a2a48abdSPL ID 795356f9-9817-4b51-8de6-4504a2a48abdSPL set ID 87de237c-febb-42ca-b2a4-b444396f8640RxCUI 248420UNII 4Q81I59GXC
- Pharmacologic class
- Aminosalicylate
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N469918056030followed by a unit qualifier and the quantityPackage 69918-0560-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
1. INDICATIONS AND USAGE Mesalamine Rectal Suppositories are indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. Mesalamine Rectal Suppositories are an aminosalicylate indicated in adults for the treatment of mildly to moderately active ulcerative proctitis. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 69918-560
- What is NDC 69918-560?
- 69918-560 is the product NDC for Mesalamine Rectal (mesalamine), Mesalamine 1000 mg/1 suppository, listed with the FDA by Amring Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Mesalamine Rectal (Mesalamine).
- What is the active ingredient?
- Mesalamine.
- Who is the labeler?
- Amring Pharmaceuticals Inc., NDC labeler code 69918. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Mesalamine Rectal?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.